Summary
- Profile Type
- Business Offer
- POD Reference
- BOTR20240229015
- Term of Validity
- 25 June 2024 - 25 June 2025
- Company's Country
- Turkey
- Type of partnership
- Commercial agreement
- Outsourcing agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- The company specialises in clinical and preclinical studies for the medical and medical device sectors, providing robust support for Good Practice (GxP) processes. They ensure compliance with regulations and uphold Good Manufacturing Practice (GMP) standards, offering expertise in Quality by Design (QbD), project management, and optimization of pharmaceutical quality systems.
- Full Description
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Established in 2020, the company is a contract research organization (CRO) based in Türkiye, specializing in providing comprehensive studies in both the medical and medical device industries. They offer both clinical and preclinical (in vitro and in vivo) studies to support drug research and development. Their services include:
-Comprehensive preclinical and clinical trial services
-Technical support in GxP processes
-Strategic planning for GxP goals
-Product lifecycle management
-Compliance with license requirements
-GMP compliance support in plant setup
-Quality by Design (QbD) technical support
-Project management support
-Pharmaceutical quality system development/optimization/management - Advantages and Innovations
- The company offers research and development support and provides technical assistance in Good Practice (GxP) processes. Their services are fully compatible with the standards set by the European Union (EU) and the Food and Drug Administration (FDA).
- Technical Specification or Expertise Sought
- The company aims to deliver efficient services to individuals requiring preclinical and clinical research, facilitating the acceleration of their projects with expertise that adheres to the standards of both the European Union (EU) and the Food and Drug Administration (FDA).
- Stage of Development
- Already on the market
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
- IPR status
- No IPR applied
Partner Sought
- Expected Role of a Partner
- The company is seeking to collaborate with small and medium-sized enterprises (SMEs) with fewer than 50 employees, as well as research and development (R&D) institutions, under either a commercial agreement or an outsourcing agreement.
- Type and Size of Partner
- SME <=10
- R&D Institution
- SME 11-49
- Type of partnership
- Commercial agreement
- Outsourcing agreement
Dissemination
- Technology keywords
- 03004011 - Care, Hygiene, Beauty
- 06001015 - Pharmaceutical Products / Drugs
- 06001002 - Clinical Research, Trials
- 03004007 - Pharmaceutics
- 06001013 - Medical Technology / Biomedical Engineering
- Market keywords
- 05004004 - Medical instruments
- 05007007 - Other medical/health related (not elsewhere classified)
- 04009 - In vitro Testing, Trials
- 05007002 - Pharmaceuticals/fine chemicals
- Sector Groups Involved
- Health
- Targeted countries
- All countries